Optimi Health Gets Analysis Certificate for MDMA GMP Capsules

Optimi Health Corp., a prominent Canadian GMP-licensed manufacturer of psychedelics, including botanical psilocybin and MDMA, has achieved a significant milestone. The company received a Certificate of Analysis (COA) from an independent third-party lab, confirming that its MDMA formulation meets Good Manufacturing Practice (GMP) standards. This certification is crucial for ensuring the quality and consistency of pharmaceutical products. Optimi has also completed the validation process for encapsulating the active pharmaceutical ingredient (API) in two dosage forms, 40mg and 60mg, capable of producing batch sizes up to 1,000 capsules.

The COA verifies essential aspects of the final product, such as content uniformity, microbial and water content, and dosage strength. Additionally, stability testing confirmed that the MDMA API remains stable within the capsules under both real-time and accelerated storage conditions for up to three months. Dr. Preston Chase, Chief Science Officer at Optimi, expressed satisfaction with the results, highlighting the team's commitment to exceeding regulatory and GMP compliance standards, particularly in terms of dosage uniformity, dissolution, and stability. Optimi now stands as one of the few companies globally offering MDMA 40mg and 60mg GMP capsules.

The MDMA API used in these capsules boasts a remarkable purity level of 99.95%. Bill Ciprick, CEO of Optimi, emphasized the company's dedication to quality and reliability in every aspect of its operations. Completing the validation and stability tests underscores Optimi's commitment to producing drug candidates that adhere to the highest GMP standards, ensuring consistency and reliability.

In a corporate update, Optimi announced plans to close the third and final tranche of its non-brokered private placement offering. The offering consists of units priced at CAD$0.30 per unit, aiming to raise gross proceeds of up to CAD$1,500,000. The company has already raised CAD$955,010, with CAD$555,010 closing on February 23, 2024, and CAD$400,000 closing on May 10, 2024, as part of the second tranche. Each unit includes one common share and one-half of a transferable common share purchase warrant. Each whole warrant allows the holder to acquire one common share at CAD$0.40 for two years from the issuance date, subject to an accelerated expiry provision.

Optimi intends to use the proceeds from this offering to obtain its Drug Establishment License, facilitate commercialization, and for general working capital. The second tranche saw participation from Directors JJ Wilson and Dane Stevens, constituting a "related party transaction" as defined in Multilateral Instrument 61-101. Post-acquisition, JJ Wilson, Chair of the Board, holds 7,674,167 common shares (8.48% of the company), and Dane Stevens, Chief Marketing Officer, holds 9,667,900 common shares (10.68% of the company).

The company is relying on exemptions from the valuation and minority shareholder approval requirements of MI 61-101, as the fair market value of the insiders' participation does not exceed 25% of Optimi's market capitalization. All securities issued in the second tranche, including those issuable upon exercise, are subject to a hold period expiring September 11, 2024, in line with exchange rules and Canadian securities laws.

Optimi Health Corp. focuses on producing and supplying psychedelic substances like MDMA and GMP-grade psilocybin for clinical research. The company aims to become the leading supplier of safe drug candidates globally, with products manufactured at its facilities in Princeton, British Columbia.